FDA.reportPublic FDA data

S-ICD® System Magnet

Primary DI
00802526531033
Brand
S-ICD® System Magnet
Company
CAMERON HEALTH, INC.
Model
4730
Device description
Magnet
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110042000
P110042017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110042000SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042017SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526531033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526531033008025265310338025265310330802526531033

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator test magnetA magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017134557
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526521300SQ-RX® PULSE GENERATOR10102014-09-24
00802526562808SQ-RX® PULSE GENERATOR10102014-09-24
00802526563201The Q-TRAK™ Subcutaneous Electrode34002014-09-24
00802526542206Q TECH32002014-09-24
00802526524806S-ICD® System Patient Screening Tool47442014-09-24
00802526531019The Q-GUIDE™ Electrode Insertion Tool47102014-09-24
00802526542244Q-TECH™32042015-01-08
00802526553707HP OFFICEJET 100 Mobile Printer47002014-09-24
00802526569401The Q-GUIDE™ Electrode Insertion Tool47102014-09-24

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Primary DI, Brand, Company table
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